Guidelines for medical devices registration in China have new development plans released by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on April 4, 2023.
The development plans cover the new implementation and amendments of technical review guidelines for class II and III medical devices in China. For both class II and III medical devices, the CMDE released a list of 59 new technical review guidelines to be implemented and 59 existing technical review guidelines to be revised.
Guidelines for Class III medical devices
- According to the CMDE, 36 guidelines will be developed for the technical review of registration applications for class III medical devices including but not limited to the following:
- Nitric oxide therapy instrument registration review guidelines
- ECMO system clinical evaluation registration review guidelines
- HLA-B27 gene test registration review guidelines
- Hydrogel dressing product registration review guidelines
- Antibiotic drug sensitivity testing reagents registration review guidelines
- Moreover, 27 existing guidelines will be revised for class III medical devices. Here are some of the guidelines being covered for reference:
- Mobile medical device registration review guidelines
- High frequency surgical devices registration review guidelines
- Classification of medical device registration units guidelines
Guidelines for Class II medical devices
- CMDE also plans to develop 23 guidelines for the registration review of class II medical devices. The list of technical review guidelines cover but are not limited to the following:
- Rehabilitation training bed registration review guidelines
- Medical gas alarm system registration review guidelines
- Electrolyte analyzer registration review guidelines
- Laser positioning system product registration review guidelines
- Nebulizer mask product registration review guidelines
- 32 existing guidelines for class II medical devices registration review are announced in the development plans. Some of these technical review guidelines cover:
- X-ray diagnostic equipment (class II) registration review guidelines
- Electronic blood pressure monitor (oscillometric method) registration review guidelines
- Urine Analyzer Registration Review Guidelines
In recent years, the CMDE has continued to promote the formulation and revision of medical registration review guidelines. China’s medical devices registration management technical support system continues to improve, and medical device product safety and effectiveness evaluation tools are becoming increasingly mature. As of 2022, 529 medical devices registration review guidelines have been issued.
Read the original CMDE announcement on the development plans for the new implementation and amendments of technical review guidelines for medical devices registration in 2023.
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